Skip to main content
OpenTrials
Completed

NCT Number: NCT07520903

Titanium-Reinforced PTFE Membranes for Bone Augmentation

This prospective comparative clinical study evaluated vertical and horizontal bone gain after guided bone regeneration using titanium-reinforced dense PTFE (TiR-dPTFE) membranes versus reinforced PTFE mesh (RPM) in patients requiring ridge augmentation prior to implant placement. Radiographic outcomes were assessed using CBCT at baseline, 9 months, and 12 months. Histological evaluation was performed in selected cases. Healing events and complications were recorded.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Alveolar Ridge Deficiency Alveolar Bone Loss Bone Diseases Bone Resorption Jaw Atrophy Mouth Diseases Musculoskeletal Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dental Medicine, University of Porto

Porto, Porto District, 4200-393, Portugal

About this study

This prospective comparative case series investigated the clinical and radiographic performance of two non-resorbable barrier membranes used for guided bone regeneration (GBR): titanium-reinforced dense PTFE (TiR-dPTFE) and reinforced PTFE mesh (RPM).

Fourteen patients presenting alveolar ridge defects requiring vertical and/or horizontal augmentation prior to implant placement were consecutively enrolled. A total of 46 defect sites were treated using autogenous bone mixed with anorganic bovine bone mineral and covered with either TiR-dPTFE or RPM membranes.

Vertical bone gain (VBG) and horizontal bone gain (HBG) were measured on standardized CBCT cross-sections at baseline, 9 months, and 12 months. Histological evaluation of regenerated bone was performed in selected cases at re-entry. Adverse events and healing outcomes were recorded throughout follow-up.

The study aimed to compare dimensional bone regeneration outcomes and safety between the two GBR approaches.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years
  • Partial or total edentulism requiring guided bone regeneration prior to implant placement
  • Presence of vertical alveolar bone defect >3 mm
  • Full-mouth plaque score <10%
  • Full-mouth bleeding on probing score <10%
  • Ability to understand study procedures and provide written informed consent
  • Provision of written informed consent prior to enrollment

Exclusion criteria

  • History of radiotherapy in the head and neck region
  • Smoking
  • Alcoholism or substance abuse
  • Untreated or active periodontitis
  • Pregnancy or breastfeeding
  • Participation in another clinical trial within the previous 30 days
  • Medical or behavioral conditions that could interfere with study participation or outcome evaluation, including poor compliance or unreliability

Treatment and study plan

Titanium-reinforced dense PTFE membrane (TiR-dPTFE)

Device

Guided bone regeneration (GBR) surgery for vertical and/or horizontal ridge augmentation prior to implant placement using a titanium-reinforced dense polytetrafluoroethylene membrane (TiR-dPTFE) to stabilize a particulate graft composed of autogenous bone chips and anorganic bovine bone mineral (60:40 ratio). The membrane was adapted to the defect morphology, stabilized with titanium fixation pins, and covered with a resorbable collagen membrane before tension-free primary closure. After 9 months, membrane removal and implant placement were performed with secondary protective augmentation (70:30 ABBM/autogenous). Allocation followed a prospective comparative protocol based on clinical indication.

Reinforced PTFE mesh (RPM)

Device

Guided bone regeneration (GBR) surgery for vertical and/or horizontal ridge augmentation prior to implant placement using a reinforced PTFE mesh (RPM) to stabilize a particulate graft composed of autogenous bone chips and anorganic bovine bone mineral (60:40 ratio). The membrane was adapted to the defect morphology, stabilized with titanium fixation pins, and covered with a resorbable collagen membrane before tension-free primary closure. After 9 months, membrane removal and implant placement were performed with secondary protective augmentation (70:30 ABBM/autogenous). Allocation followed a prospective comparative protocol based on clinical indication.

Primary outcomes

  1. Vertical Bone Gain (VBG)

    Time frame: 9 months and 12 months after guided bone regeneration surgery

    Vertical bone gain (mm) measured using standardized cone beam computed tomography (CBCT) cross-sectional images by comparing baseline measurements before guided bone regeneration with measurements obtained at follow-up. Measurements were performed using matched anatomical landmarks and calibrated digital image analysis software.

    Measurements were performed at the implant-site level with clustering within participants considered during statistical analysis.

Secondary outcomes

  1. Horizontal Bone Gain (HBG)

    Time frame: 9 months and 12 months after guided bone regeneration surgery

    Horizontal bone gain (mm) measured using standardized cone beam computed tomography (CBCT) cross-sectional images by comparing baseline ridge width measurements before guided bone regeneration with follow-up measurements obtained at 9 and 12 months using calibrated digital image analysis.

  2. Postoperative Healing Complications

    Time frame: From surgery to 12 months after guided bone regeneration

    Incidence of postoperative complications including membrane exposure, infection, wound dehiscence, or need for additional surgical intervention recorded during the healing period following guided bone regeneration.

  3. Histological Characteristics of Regenerated Bone

    Time frame: 9 months after guided bone regeneration surgery

    Qualitative histological assessment of regenerated bone tissue obtained from core biopsies at re-entry surgery to evaluate bone vitality, graft integration, lamellar structure, and absence of inflammatory or necrotic tissue in selected cases.

Sponsors and collaborators

Lead sponsor

Universidade do Porto

Other

Registry information

Official study title

Vertical and Horizontal Ridge Augmentation With Titanium-Reinforced Dense PTFE Versus Reinforced PTFE Mesh: A Prospective Comparative Case Series

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 9, 2026
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.